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Biogen Idec Canada Inc

⚠️ High Risk

FEI: 3010396850 • Mississauga, ON • CANADA

FEI

FEI Number

3010396850

📍

Location

Mississauga, ON

🇨🇦

Country

CANADA
🏢

Address

90 Burnhamthorpe Rd W #1100, , Mississauga, ON, Canada

High Risk

FDA Import Risk Assessment

53.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

3
Total Refusals
1
Unique Violations
4/16/2024
Latest Refusal
10/11/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
50.2×20%
Frequency
2.9×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
4/16/2024
58MCY05INTERFERON BETA-1A
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/11/2013
66YAB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Detroit District Office (DET-DO)
10/11/2013
66YAB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Biogen Idec Canada Inc's FDA import refusal history?

Biogen Idec Canada Inc (FEI: 3010396850) has 3 FDA import refusal record(s) in our database, spanning from 10/11/2013 to 4/16/2024.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Biogen Idec Canada Inc's FEI number is 3010396850.

What types of violations has Biogen Idec Canada Inc received?

Biogen Idec Canada Inc has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Biogen Idec Canada Inc come from?

All FDA import refusal data for Biogen Idec Canada Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.